Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067392
Status:
UNKNOWN
Last Update Posted:
2010-11-09
First Post:
2003-08-15
Brief Title:
Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Louisiana State University Health Sciences Center in New Orleans
Study Overview
Official Title:
Prospective Evaluation of Immediate Temporized Implants
Status:
UNKNOWN
Status Verified Date:
2008-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed In addition the level of bone around the implants will be compared to determine if one method leads to better results over time
Detailed Description:
This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50 of cases requiring hard and soft tissue grafting to achieve a functional result Additional preliminary data indicates that grafting the extraction site andor immediate implant placement and provisionalization results in a functional restoration without the need for additional adjunctive grafting procedures It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement in contrast to immediate implant placement with immediate provisionalization with a crown We hypothesize that there will be differences in the crestal bone levels primary endpoint and differences in soft tissue levels and indices secondary endpoints between implants immediately temporized placed either delayed or immediately after tooth extraction with more bone loss in the immediate placement group experimental compared to the delayed placement group control The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone Two groups of 45 patients will be evaluated All subjects will have a single rooted maxillary tooth extracted One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement The crestal bone in this group will have remodeled during the four months of healing prior to implant placement The second group will have the implant placed immediately after tooth extraction thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration as a one-stage procedure For both groups the implants will be immediately temporized with a crown after implant placement Standardized hard and soft tissue data will be collected pre-extraction as baseline and then prospectively for at least two years in this trial to compare the methods and contrast the effectiveness of the proposed immediate restoration therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE014185 | NIH | None | httpsreporternihgovquickSearchR01DE014185 |